84 Clinical Trials for Various Conditions
Inflammation and stressors can interfere with the function of the lining of blood vessels and insulin activity, therefore, investigators are aiming to see how the Grape seed Extract (GSE) called MegaNatural BP can help with limiting the effects of these factors. This research will study the effects of taking 150mg of MegaNatural BP GSE per day on blood pressure levels along with influences on heart health through assessing the function of the blood vessel lining and levels of inflammation.
The aim of the proposed study is two-fold: to determine whether the intake of peanuts (a) enhances immune function and (b) produces a desirable impact on selected cardiometabolic biomarkers and risk factors.
The purpose of this study is to assess how time restricted eating interventions impact eating behaviors, diet quality, and body composition in women ages 20-29 years. Participants will be asked to limit all food and drinks (except water and some non-caloric beverages) to a 10-hour period during the day for four weeks. Participants will follow their usual eating and activity patterns for one week before starting, and follow whatever eating pattern they want for 4 weeks after finishing.
More than 40% of young adults with type 1 diabetes (T1D) also have overweight or obesity. Each of these diagnoses increase the risk of adverse cardiovascular events. Investigators aim to obtain reference data for individuals with T1D who do not have overweight obesity, to understand how close GLP-1 analogue obesity treatment in those with overweight/obesity brings physiologic markers of cardiometabolic risk to those with BMI in the normal range. Specifically, investigators will describe how drivers of gluconeogenesis and lipemia (specifically measured as visceral fat ratio, insulin resistance, and postprandial lipemia,) that contribute to cardiometabolic risk in T1D change over time.
This research study will determine the effects of mango consumption on blood pressure, body weight, dietary nutrient/pattern changes, total cholesterol, LDL-cholesterol, VLDL-cholesterol, triglycerides, and HDL-cholesterol in individuals with moderately elevated blood pressure and/or LDL-cholesterol.
The purpose of this interventional sham-controlled pilot study is to study the effects of using portable air cleaners (PACs) in outpatient adults with prediabetes. The primary aims are to determine the effect PAC's have on glycemic variability and the concentrations of circulating biomarkers of inflammation.
This study is designed as a two-group parallel randomized controlled trial (N=50) to test effects of 8-weeks of Qigong/Tai Chi (QTC) intervention compared to QTC plus HRVB on HRV parameters (primary), and cardiometabolic risk factors and sequelae (secondary) (e.g., BMI, waist circumference/percent body fat, sleep quality, stress, anxiety/depression, emotional regulation, eating behaviors, and cognitive performance).
The aim of this project is to trial the protocol of a park-based physical activity (PA) intervention in adults with serious mental illness (SMI) in a community mental health center's peer support program.
Heart disease and diabetes are leading causes of death and disability in the US, especially among Veterans. Posttraumatic stress disorder (PTSD) is a disabling condition that also affects many Veterans. New research suggests that PTSD further increases the risk of developing heart disease and diabetes. What causes this increased risk is unknown. However, individuals with PTSD are often less physically active and make more unhealthy dietary choices than individuals without PTSD. Maintaining a physically active lifestyle, staying physically fit, and eating a healthy diet may be important for reducing the PTSD related risk for heart disease, diabetes and disability. The proposed research seeks to assess how important these lifestyle factors are for reducing the risk of heart disease, diabetes and disability in Veterans with and without PTSD. A better understanding of these lifestyle factors and cardiometabolic health in Veterans will help to clarify how lifestyle interventions can best be applied to the prevention and treatment of long-term disability in Veterans. Aim 1: To examine physical activity participation as a mechanism linking PTSD to cardiometabolic health and functioning in post-9/11 Veterans. This study will longitudinally assess associations between PTSD diagnosis, physical activity, cardiometabolic health, and functioning over time in 250 TRACTS participants. H1-1: Total self-report physical activity will mediate the effects of PTSD on cardiometabolic health and functioning over time, such that lower physical activity will increase the detrimental effect of PTSD on cardiometabolic health and functioning. H1-2: physical activity intensity will moderate the effect physical activity has on cardiometabolic health and functioning. Aim 2: To examine diet quality as a mechanism linking PTSD to cardiometabolic health and functioning in post-9/11 Veterans. This study will longitudinally assess associations between PTSD diagnosis, diet quality, cardiometabolic health, and functioning over time in 200 TRACTS participants. H2: Self-report dietary intake will mediate the effects of PTSD on cardiometabolic health and functioning over time, such that a poor diet will increase the detrimental effect of PTSD on cardiometabolic health and functioning. Supplemental Aim: To validate the use of a self-report clinical measure of physical activity against objective measure obtained via accelerometry. Objective measurement of physical activity is not often accessible or feasible for VA providers (e.g., time constraints). It is essential that quick self-report physical activity measures accurately reflect the physical activity of Veterans. This study will compare data from a self-report clinical physical activity measure to objectively measured physical activity/sedentary time (i.e., accelerometry), cardiorespiratory fitness, cardiometabolic health, functioning, and PTSD symptom severity in 100 post-9/11 Veterans. H1A-1: Self-report and objective measurement of physical activity will be significantly correlated. H1A-2: Both self-report and objectively measured physical activity/sedentary time will be associated with cardiorespiratory fitness, cardiometabolic health, functioning, and PTSD symptom severity.
The primary purpose of this proof-of-activity, phase 2 trial is to evaluate the safety and activity of orticumab in subjects with moderate to severe psoriasis and cardiometabolic risk factors.
This study will test whether a culturally-tailored nutrition and exercise intervention designed for African-American women will lead to sustained improvements in exercise and healthy eating through improvements in self-management mediators: mindfulness, stress management, positive reappraisal, self-regulation, and self-efficacy.
The goal of this research study is to learn more about the hormones that muscles make during exercise, and if those hormones are associated with type 2 diabetes risk in adults who are overweight or obese. Participants will undergo exercise testing on an upright bicycle, with blood samples taken for muscle hormones before and after exercise. The hypothesis is that adults with overweight/obesity and insulin resistance will have an impaired muscle hormone profile in response to exercise compared to adults with overweight/obesity who are not insulin resistant.
The purpose of this study is to quantitate hepatic de novo lipogenesis (DNL) in youth with poorly-controlled type 1 diabetes (T1D) (HbA1c \>8.5%), youth with T1D who achieve targeted glycemic control (HbA1c \<7.5%) and lean controls. Hypothesis: Youth with poor glycemic control experience higher fractional hepatic DNL during the fasting and the postprandial states than youth who achieve targeted glycemic control and lean controls.
This research study will test the effects of macadamia nuts on adiposity, and traditional and emergent risk factors of cardiometabolic disease in adult men and women
Obesity and pre-diabetes threatens the overall health and functional independence of older adults but lifestyle weight management for diabetes prevention, soon to be reimbursed by Medicare, can reduce this burden. The current 24-month study will enroll adults, ages 60 and older, through senior community centers and research registries. The investigators will study how two long term weight loss maintenance programs, both using group telephone sessions to support health behavior change, impact meaningful health outcomes. If successful, this project will provide a sustainable intervention model for healthy aging services that can benefit older adults and society.
Time-restricted feeding (TRF) is a novel type of intermittent fasting that involves eating within a daily period of 10 hours or less, followed by fasting for at least 14 hours daily. Several studies in rodents report that TRF reduces body weight, improves blood sugar control, and reduces the risk of cardiovascular disease-even when food intake is matched to the control group or no weight loss occurs. Preliminary evidence suggests that TRF may also increase weight loss, fat loss, and reduce the risk of diabetes and cardiovascular disease in humans. This study will test whether TRF enhances fat loss and increases weight loss in adults with obesity, relative to conventional dieting alone. In addition, this study will determine whether TRF reduces risk factors for type 2 diabetes and cardiovascular disease and will measure the feasibility and acceptability of TRF. In conjunction with the parent study described above, four ancillary studies will be conducted: 1. Effect of weight loss on nitrogen metabolism and bacteria in the mouth. The primary endpoints for this ancillary study are plasma and salivary nitrate and nitrite, and the secondary endpoints are salivary nitrate reductase activity and salivary bacterial abundance. 2. Effect of weight loss on several biomarkers related to kidney stones. The primary endpoint for this ancillary study is urinary oxalate, and the secondary endpoints are urinary citrate, chloride, sodium, potassium, calcium, phosphorus, uric acid, and creatinine. 3. Effect of meal timing on blood pressure regulation and kidney function. The primary endpoints of this ancillary study include urinary aldosterone excretion, sodium, potassium, and endothelin, whereas the secondary endpoints include nitric oxide and albumin. Additional exploratory endpoints include renal injury markers (KIM-1, nephrin, and urine albumin-to-creatinine ratio), measures of reactive oxidative stress (e.g., hydrogen peroxide and TBARs), and urinary exosomes. Urine will be analyzed in 12-hour bins to determine how meal timing affects differentially affects these endpoints during the daytime and nighttime. The effects of weight loss on these endpoints may also be considered. 4. Validation of a meal timing questionnaire to assess the distribution of food intake throughout the day.
This research study will test the effects of Q CAN PLUS powder on serum lipids, selected inflammatory and oxidative parameters and genome-wide methylation
Background: Extracellular RNAs (exRNAs) send genetic data from cell to cell. This is how they affect the way cells communicate with each other. There are many types of exRNA, and they each serve different roles. But they have also been linked to some diseases. Researchers want to measure exRNAs to see how they relate to certain traits over time. They will use blood samples that were taken as part of the Framingham Heart Study (FHS). Objectives: To identify cross-sectional associations of exRNAs with age, sex, and cardiometabolic risk factors. Eligibility: People ages 30-70 who had blood taken as part of the FHS Third Generation cohort. Design: Researchers will study samples that have already been collected in the FHS. There will be no active participant contact for this project, only use of data that are collected as part of planned follow up from other studies. As part of the FHS, participants gave blood samples. They gave permission for the blood to be used for research. The exRNAs from the blood samples will be studied to see how they relate to certain traits. These include age, sex, and body mass index. The exRNAs will also be studied for their usefulness as biomarkers of risk for subclinical atherosclerotic cardiovascular disease. No study participants will be contacted for this study....
This study is a secondary analysis of data collected in the Nurses' Health Study (NHS) that will evaluat the association between intake of sugar sweetened beverages (SSB), juice and artificially sweetened beverages in relation to biomarkers of hepatic function, lipid metabolism, inflammation and glycemic control.
The purpose of the study is to compare the relative contribution of systemic inflammation vs. Obstructive Sleep Apnea (OSA) severity (as measured by Apnea Hypopnea Index) in predicting cardiovascular and metabolic aberrations associated with mild-to-moderate obstructive sleep apnea.
This is a 2-period randomized crossover study with free-living subjects on self-selected diets. The objective of this study is to compare the effects of ¾ cup of a blend of dried plums, figs, dates and raisins (DPFDR) with an isocaloric and macronutrient matched snack food on blood pressure, vascular health and lipids and lipoproteins in 50 participants who are representative of the U.S. population and at risk for cardiovascular disease (overweight/obese, elevated LDL-cholesterol, prehypertension, and/or prediabetes). The investigators hypothesize that the inclusion of DPFDR in the diet will decrease blood pressure and LDL-cholesterol, and improve artery function (assessed by standard blood pressure measure, 24 hr ambulatory blood pressure, central blood pressure and arterial stiffness) compared to the control group and baseline.
In a 12 week double-blind, placebo-controlled randomized trial, 120 subjects with obesity (BMI≥30 kg/m2) and pre-diabetes (HbA1c, 5.7-6.4%) will be randomly assigned 1:1 to receive either placebo or 2 mg of controlled-release melatonin, taken orally every evening 1 hour before bed. The investigators will assess melatonin's effect on insulin sensitivity by performing a hyperinsulinemic euglycemic glucose clamp and β-islet cell function measured using a hyperglycemic clamp, as a primary endpoint. The investigator will also evaluating melatonin supplementation's effect on mean 24-hour ambulatory blood pressure, nocturnal blood pressure, and potential intermediates including endothelial function using brachial ultrasound, catecholamine production using 24-hour epinephrine and norepinephrine excretion, and renin-angiotensin system activation using measurements of plasma renin activity, angiotensin II, and urine aldosterone excretion. The final endpoint will be to evaluate melatonin supplementation's effect on cellular cytokine and CC family chemokine expression as well as high sensitivity C-reactive protein, IL-6, and TNF-α. There will be a 24 week cohort phase as an extension of the trial. This will be an open-label prospective study of 50 subjects recruited from the trial who will take 2 mg of controlled-release melatonin nightly for 24 weeks after completion of the 12-week trial. At the end of the cohort-phase (36 weeks after entry in the trial), the investigators will again assess the extended use of melatonin supplementation on 24-hour BP, and glycemic control (HbA1, fasting glucose).
The purpose of this study is to examine the effectiveness of a low carbohydrate diet on increasing dietary adherence and improving cardiometabolic risk factors among adults with spinal cord injury (SCI). Seventy overweight/obese adults with SCI will be randomized to one of two groups: 1) a reduced carbohydrate diet or 2): a "standard" diet (STD). Participants will take part in a 6-month behavioral lifestyle intervention implemented through a novel eHealth platform specially designed for individuals with SCI.
This study will test the effect of both Luna Rich X© and Reliv Now© against placebo pills or powder (control) on blood lipids. It will also explore the potential effects of these dietary supplements on inflammation markers and other biological and anthropometric measures. The study intervention will be 30 weeks in length. Twenty four subjects with 2 or more cardiometabolic risk factors will be randomized to participate in the study.
The primary goal is to characterize the acute effects of avocado intake on glycemic and satiety/ appetite responses in relatively healthy overweight / obese adults. The secondary goal is to investigate risk factors for cardio-metabolic disease.
The proposed research brings together complementary expertise to systematically elucidate the longitudinal effects of (1) total and regional body fat and (2) the metabolic impairment that accompanies obesity on bone development during growth. The contribution of this research will be significant because it will provide a solid foundation for understanding the influence of fat (total and regional distribution) on overall bone strength, and whether insulin resistance, beta-cell dysfunction, abnormal lipids, and inflammation could be underpinning factors in the fat-bone strength relationship via effects on bone modeling activity. This knowledge will provide critical information needed to maximize potential therapeutic interventions to counter the linked risks of obesity and osteoporosis, both major public health concerns.
1. Primary Objectives: * To characterize cardiometabolic risk factor profiles of patients entering cardiac rehab using traditional approaches (eg LDL-C) as well as a more comprehensive panel of cardiovascular and metabolic biomarkers. It is hypothesized that the comprehensive panel will identify further increased risk that would not have been detected using only traditional approaches. Specifically, it is hypothesized that a greater percentage of the cohort will be identified with "high risk" levels of LDL-P (\>1100 nmol/L) and/or apoB (\>80 mg/dL) than of LDL-C (\>100 mg/dL). It is further hypothesized that the prevalence of elevated Lp(a) and elevated levels of inflammatory and insulin resistance markers will be higher in this cohort when compared to population norms (HDL, inc reference data). * To assess improvements in laboratory and lifestyle risk factors and rate of goal attainment at completion of rehab (eg 3 months). This objective is primarily descriptive, and improvements in traditional risk factors (eg LDL-C) will be compared to existing published data. Improvements in non-traditional risk factors (eg LDL-P, insulin resistance markers) in a cardiac rehab population have not been extensively investigated. * To determine which attributes at baseline best predicted recurrent events and re-hospitalizations assessed one year later. 2. Secondary/Developmental Objective: * To inform and guide development of a subsequent study protocol designed to compare outcomes associated with biomarker-guided personalized treatment plans vs. standard of care in the cardiac rehab setting.
The purpose of this research is to determine what supplemental doses of vitamin D may be necessary to raise serum levels to optimal levels and how vitamin D supplementation and changes in vitamin D status impact cardiovascular risk factors in schoolchildren.
The purpose of this study is to identify salivary biomarkers for monitoring cardiometabolic risk in children. The study hypothesis is that a combination of salivary biomarkers will predict the presence of risk factors including impaired fasting glucose, hypertension and dyslipidemia and will reflect changes in these risk factors over time.
The hypothesis for this study is that children with sleep disordered breathing will benefit from treatment with Continuous Positive Airway Pressure (CPAP) or Bi-level Positive Airway Pressure (BiPAP) in terms of reduction in cardiovascular risk markers and insulin resistance. The CPAP machine delivers a predetermined level of pressure. It releases a stream of compressed air through a hose to the nose mask and keeps the upper airway open under continuous air pressure. This air pressure prevents obstructive sleep apnea, which occurs as a result of narrowing of the airway due to the relaxation of upper respiratory tract muscles during sleep. This machine helps to increase the oxygen flow by keeping the airway open. The BiPAP machine delivers two levels of pressure. Inspiratory Positive Airway Pressure (IPAP) is a high amount of pressure, applied when the patient inhales and a low Expiratory Positive Airway Pressure (EPAP) during exhalation.